[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602227":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":39,"locations":45,"responsibleParty":65,"collaborators":30,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":30,"eligibilityCriteria":74,"healthyVolunteers":71,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":30,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":30,"overallStatus":48,"whyStopped":30,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"State University of New York at Buffalo","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Full ketamine sedation","ACTIVE_COMPARATOR","Including group of patients treated with full ketamine sedation in setting of distal radius fracture reduction",[13],"Drug: Ketamine group",{"label":15,"type":10,"description":16,"interventionNames":17},"Hematoma block\u002Fminimal ketamine pain control","Including group of patients treated with hematoma block\u002Fminimal ketamine pain control (. 0.25mg\u002Fkg) for distal radius fracture reduction in pediatric patients requiring reduction",[18],"Drug: Ketamine + Lidocaine",{"label":20,"type":10,"description":21,"interventionNames":22},"hematoma block\u002Fintranasal fentanyl","Including control group of patients treated with intranasal fentanyl and hematoma block, utilized in the setting of distal radius fractures in pediatric patients requiring reduction",[23],"Drug: Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)",[25,31,34],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Ketamine + Lidocaine","Including comparisons between patients randomized for treatment with full ketamine sedation in setting of distal radius fracture reduction, hematoma block\u002Fminimal ketamine pain control (. 0.25mg\u002Fkg) for distal radius fracture reduction, or intranasal fentanyl and hematoma block, utilized in the setting of distal radius fractures in pediatric patients requiring reduction",[15],null,{"type":26,"name":32,"description":28,"armGroupLabels":33,"otherNames":30},"Ketamine group",[9],{"type":26,"name":35,"description":28,"armGroupLabels":36,"otherNames":37},"Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)",[20],[38],"fentanyl + lidocaine",[40],{"name":41,"role":42,"phone":43,"phoneExt":30,"email":44},"Dr. Ellen Lutnick Lutnick, MD","CONTACT","(716) 323-2100","ellenlut@buffalo.edu",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Oshei Children's Hospital","RECRUITING","Buffalo","New York","14203","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-78.87837,42.88645,{"lat":58,"lon":57},[61],{"name":62,"role":42,"phone":63,"phoneExt":30,"email":64},"Dr. Tara Petroski Emergency Medicine Physician, MD","716-323-2100","tpetroski@upa.chob.edu",{"type":66,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"PRINCIPAL_INVESTIGATOR","Tara Petroski","Principal Investigator","100602227","phase-3-pain-control-alternatives-in-pediatric-patients-with-distal-radius-fractures-100602227",false,"NCT07120763","Pain Control Alternatives in Pediatric Patients With Distal Radius Fractures","Inclusion Criteria:\n\n* Children requiring reduction for distal radius fracture\n* Children presenting to the emergency department\n* Children who are ages 3 to 17 years.\n\nExclusion Criteria:\n\n* Pediatric patients \\\u003C3 years old\n* Adult patients (i.e. ages 18 or up)\n* Pediatric patients with injury patterns that are not amenable to hematoma block.\n* Children who are not a candidate for sedation related to BMI \\> 95%tile for age, ASA class \\> 2, Mallampati score \\> 2, and pregnant patients","ALL","3 Years","17 Years",{"count":79,"type":80},50,"ESTIMATED","INTERVENTIONAL",[83],"PHASE3","The aim of this study is to evaluate the efficacy of a hematoma block and minimal ketamine pain control or hematoma block and intranasal fentanyl in pediatric patients presenting with distal radius fractures requiring reduction, compared to control of standard full conscious sedation using ketamine.",[86,87,88],"Distal Radius Fracture Reduction","Pain Control","Pediatric Fractures","2025-10-08",{"date":91,"type":92},"2025-10-10","ACTUAL",{"date":94,"type":92},"2025-08-22",{"date":96,"type":80},"2027-08-22",{"name":5,"class":6},1]